Government Reform and Oversight Committee
February 4, 1998
Chairman Dan Burton
"Patient Access to Alternative Treatments: Beyond the
FDA"
Good morning. Today we will begin a series of hearings to
examine issues and problems related to alternative medical
treatments for millions of desperately ill Americans. We will
also look at deep-seated flaws in the process of the Food
and Drug Administration (FDA) that governs access to some
of these treatments.
These issues are at times controversial. My purpose in holding
these hearings is to lay the issues out on the table, and
deal with them in the most reasonable and balanced way. I
want to stress that in no way is this a partisan issue. Dedicated
Members from both parties have raised concerns about patient
access. We owe it to the millions of patients, their families
and loved ones who are not satisfied with conventional treatments.
Health is the first of all liberties. And each person is
the proper guardian of his or her own health. Yet in our system
of health care, personal choice in treatments is all too often
not an option. The FDA often comes in the way of our choices
of alternative medicines.
Medicine is a matter of weighing the benefits of a treatment
against any possible harm that might result. At times, federal
health care agencies seem to put much more energy and effort
into avoiding harm than we do into weighing the benefits.
This, despite the fact that conventional medicine sanctioned
by the FDA offers some highly toxic, extremely expensive and,
at times, only marginally successful treatments for most deadly
illnesses.
For example, more than 25 years have passed since President
Richard Nixon first declared war on cancer. He predicted a
cure within five years. So far, cancer has won. We have no
cure, and made only little progress in developing cures. Meanwhile,
we know that half a million people will die from cancer this
year. There are growing numbers among them who will depart
from conventional treatments because they are too toxic, too
expensive and less effective.
The same can be said of other serious diseases, such as multiple
sclerosis, hepatitis C, arthritis, asthma and many others.
The meager advances by conventional medicine in the treatment
of these diseases has made alternative and complementary therapies
overwhelmingly popular. Indeed, more than 45 percent of Americans
will use some alternative therapy this year. And, they will
pay for it out of their own pockets. Who can blame them for
searching against hope for a cure?
More and more doctors are having tremendous success in using
alternative treatments together with conventional treatments.
Others are succeeding with time-proven natural preparations
in ways that are less toxic, less damaging and often less
expensive than typical conventional therapy.
Despite the growing popularity and success of alternative
treatments, some of our government institutions are fighting
that trend. The FDA dictates what treatments doctors can use
in treating serious illnesses, but most of those are toxic
and often dangerous to already weakened patients. Meanwhile,
our government agencies have spent untold billions of dollars
trying to find elusive cures. In addition, the FDA has harbored
a culture of intimidation and sometimes harassment against
those looking for alternative cures. Today we will hear from
a researcher who is at an impasse with the FDA after spending
his career searching for a cure for cancer. He found himself
so overwhelmed by FDA paperwork requirements that, as an individual
researcher, he simply could not comply. Today, his research
is on hold with no hope to resume.
It is sometimes done under the guise of defending good science,
and weeding out fraud. But frequently it undermines the practice
of good medicine and the potential for greater advances in
possible cures. Many doctors are truly healing patients through
innovative, safe and effective measures.
At the same time, doctors who use alternative treatments
often do so at great peril to their reputations and their
right to practice medicine. It is because of the tremendous
courage of many of these doctors and their patients, that
some progress has been made with respect to alternative treatments
in this country.
They are not alone in history. It seems that all great discoveries
were met for a period of time with skepticism and ridicule.
For instance, Louis Pasteur was ridiculed for his germ theory
of disease. Dr. Ignaz Semmelweis spoke to his colleagues about
the importance preventing the passing of infection to women
in childbirth by washing their hands after an autopsy. He
was similarly ridiculed and died an early death without recognition.
Finally, there was Jonas Salk, a young doctor with the only
hope against polio. He produced a vaccine that was initially
forbidden by the medical establishment.
If anything, history teaches us that, in the long-term, those
who are ridiculed for their discoveries are often eventually
proven right. If we don't learn from history, we're doomed
to repeat it. And that makes progress difficult.. What's clearly
needed is a shift in thinking, from Government knows Better,
to The People Know Better. At least there needs to be more
of a balance.The FDA process for access to new treatments
is a good example of this need. That is why today, we will
examine options available to seriously ill patients for promising
new treatments, and also the barriers to getting access. Access
to a treatment in the development process that is not approved
by the FDA generally requires participation in a clinical
trial. But many patients do not qualify under the strict guidelines
of a trial.
The FDA then makes a life or death decision as to whether
a patient can have the treatment under a special exception.
If the answer is "no," their access is shut off, with no appeal.
Under those conditions, patients must apply through an FDA
regulatory process to try to gain access to their desired
treatment. This can be lengthy, trying and frustrating, especially
for someone who is terminally ill. And for those who do not
have the stamina, family support, sometimes legal fees, or
even congressional help, it can be a dead end.
We know from the FDA's own records that in 1996, about 500
cancer patients were given access to an experimental drug
through the FDA, compared to half a million who died that
year. We will hear compelling testimony from some of those
patients about how the FDA process is broken. If that is true,
then the Congress is obliged to find a way to fix it.
We know that the FDA process cannot accommodate half a million
people. So, in essence, we as a government are deciding who
gets treated, and how they are treated and everyone else is
on their own. We cannot tolerate that in an open society where
choice and the right to a healthier life is the first liberty.
These hearings will also explore ways to help those hundreds
of thousands who get left out of the FDA-sponsored experimental
treatments, and, therefore left out in the cold. We will hear
from patients, families, who had lost hope, and facing death,
who were up against a massive bureaucracy which seemed to
have little understanding of their pain, suffering and desperation.
I believe that if a patient is terminally ill, he should
have access to any experimental treatment on the market. He
should not have to wade through red tape, he should not have
to fight against a bureaucracy, he should not have to spend
thousands of dollars. If someone is fighting for their life,
the government ought to be helping them find new alternatives
not throwing up roadblocks.
A truly compassionate society will help find solutions to
greater access to new and promising treatments. Good health
and medicine require it.
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